CSV-validated medical device portal

The Instructions For Use (IFU) for the range of medical devices sold in 40 countries are available at a central location at karlstorz.com/ifu.
What sounds simple involves a great deal of technical complexity due to regulatory requirements regarding the form and traceability of documentation and its revisions, a large number of country/language combinations and different availability of products and product variants in the target markets.
In addition, the information available in the backend systems had to be made accessible for use in the web platform in a secure and high-performance manner - no problem for the customer thanks to the middleware-based digital platform.

Intuitive access to product information for professional users of the products was a top priority for KARL STORZ. This means that users only receive the information relevant to their country and language for their product, always in the latest version and also in previous revisions, which can be viewed at any time. In addition to the download, there is also the regulatory option of ordering the instructions in paper form via a simple ordering process.
In order to comply with the applicable regulations, the software itself and the web platform required for delivery, which is also managed by Intentive, have been successfully validated and confirmed in accordance with the high medical device standards for production and quality-related processes.